I am currently working with a medical device company developing and manufacturing cerebral embolic protection (CEP) devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain emboli associated with cardiovascular procedures. The TriGuard™ and TriGUARD 3™ devices product pipelines are designed to help interventional cardiologists and electrophysiologists preserve brain reserve in patients undergoing these procedures.

They are rapidly growing and headquartered in Florida with manufacturing in Israel, they are dedicated to advancing patient care through innovative technology and clinical research. The company's management team has extensive experience in the fields of interventional cardiology and medical devices.

Responsibilities:

* Provide global strategic and operational leadership for the planning, management, support and execution of regulatory activities.

* Ensure site-wide training is effective and that the plant operates within the required regulatory guidelines examining and testing plant-wide processes and products from a final product acceptance and compliance perspective.

* Responsible for the continued development GMP capability and maintenance of compliance to US FDA Quality System Regulation. Coordinate ISO training, certification and maintenance.

* In-depth knowledge of relevant regulatory guidelines and requirements, with a focus on the US, Canada, EU with a demonstrated record of success in gaining regulatory approval.

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If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV or call (phone number removed) for a confidential discussion about potential opportunities.

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JCW

JCW are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;

* Pharmacovigilance/Drug Safety

* Regulatory Affairs

* Quality Assurance

* Quality Control

* Medical Information

* Medical Writers

* Medical Affairs

* Compliance

* Audit

* Validation

* Production

* Manufacturing

* Clinical Trials

* Clinical Research

* Project Management

* Finance

My Linked In Profile

https://(url removed)/in/james-ben-fraj-9b178a15a/

I personally specialise in recruiting QA and validation professionals for roles across the UK so please do get in touch should you be considering new roles or looking to fill ones at your current company!